Effects of Time-restricted Hypocaloric Diet in Patients With NAFLD

Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients With Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)

The effects of a time-restricted hypocaloric Mediterranean type diet compared to a conventional hypocaloric Mediterranean type diet on blood glucose metabolism and liver steatosis in people with non-alcoholic fatty liver disease will be investigated.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding

Detailed Description

The goal of this clinical trial is to evaluate the effects of the time in which food intake is restricted (morning or evening hours or no restriction in time) on glucose metabolism and liver steatosis in the context of a hypocaloric diet plan in 54 patients with non-alcoholic fatty liver disease (NAFLD). The participants will be divided into 3 groups of 18 individuals each and will be randomly assigned to one of the 3 dietary interventions. In the first group (control group), participants will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week) with the instruction to consume their meals throughout the day, without time restriction. In the second group (early eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 07:00-09:00 and 17:00-19:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours. In the third group (late eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 11:00-13:00 and 21:00-23:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours. Finally, all groups will be instructed to moderately exercise for 150 minutes per week.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • Not yet recruiting
      • Laiko General Hospital of Athens
      • Contact: Evangelos Cholongitas, MD, PhD; Phone Number: +302132061643; Email: echolog@med.uoa.gr
      • Contact: Evangelos Cholongitas, MD, PhD; Phone Number: +302132061643; Email: cholongitas@yahoo.gr
    • Athens, Attica, Greece, 11855
      • Recruiting
      • Agricultural University of Athens
      • Contact: Aimilia Papakonstantinou, PhD; Phone Number: +302105294967; Email: apapakonstantinou@gmail.com
      • Contact: Emilia Papakonstantinou, PhD; Phone Number: +302105294967; Email: emiliap@aua.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body Mass Index >25 kg/m2
• Liver steatosis with Magnetic Resonance Elastography (MRE)

Exclusion Criteria:

• Other chronic liver diseases
• Alcohol consumption >20 g/day (female) and >30 g/day (male)
• Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid)
• Changes in body weight ± 3 % in the last 3 months
• Patients following a hypocaloric diet program and/or time-restricted feeding and/or other intermittent fasting protocols
• Unstable glucose-lowering medications in the last 6 months
• Body weight lowering medications and/or history of bariatric surgery
• Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months
• Uncontrolled type 2 diabetes mellitus defined as HbA1c value > 9.0% or insulin depending type 1 and 2 diabetes mellitus
• Pregnancy
• Lactation
• Immunologic or inflammatory diseases
• Depression and other psychiatric diseases
• Patients working in shifts
• Cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet	Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; 18 patients with NAFLD will be asked to follow an early 14:10 (14 hours fasting and 10 hours feeding) time-restricted (eating between 08:00-18:00) and individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) for 12 weeks
Experimental: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet	Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; 18 patients with NAFLD will be asked to follow a late 14:10 (14 hours fasting and 10 hours feeding) time-restricted (eating between 12:00-22:00) and individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) for 12 weeks
Active Comparator: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding; Hypocaloric Mediterranean diet without time restriction in feeding	Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding; 18 patients with NAFLD will be asked to follow an individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) without time restriction in feeding (eating throughout the day) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood glucose concentrations	Clinically significant change in blood glucose concentrations (mg/dL)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Clinically significant change in body weight (kg)	12 weeks
Change in blood insulin concentrations	Clinically significant change in blood insulin concentrations (μU/L)	12 weeks
Change in Controlled Attenuation Parameter (CAP)	Clinically significant change in CAP (dB/m)	12 weeks
Change in blood lipids levels	Clinically significant change in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl)	12 weeks
Change in Chronic Liver Disease Questionnaire (CLDQ)	Clinically significant change in health status within individuals with NAFLD. The CLDQ includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. Overall CLDQ scores calculated for each domain range from 1 (most impaired) to 7 (minimum frequency of symptoms). The total score is calculated as the average score of the 29 items.	12 weeks

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Collaborators: Laikο General Hospital, Athens

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Anticipated): July 15, 2024
• Study Completion (Anticipated): July 30, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Mediterranean Diet; Time-Restricted Feeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HRBD40/27.04.2022 716/26-11-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No